Sunosi (solriamfetol) / Jazz, SK Bio, Uniphar, Axsome Therap, Pharmanovia - LARVOL DELTA

On December 9, SK Biopharmaceuticals announced that its innovative epilepsy drug “Cenobamate“ and sleep disorder treatment “Solriamfetol“ have received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) of China. (The Asia Business Daily)

China approval • Epilepsy • Sleep Disorder

"Too small to succeed?" Rethinking efficacy claims in a solriamfetol trial for ME/CFS. (PubMed, J Psychopharmacol) - No abstract available

Journal

Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof). (PubMed, CNS Drugs) - "Among 24 distinct compounds studied, only 1 agent, lisdexamfetamine dimesylate, received approval from the U.S. Food and Drug Administration (FDA) for an ED during this period...While some emerging agents show promise, such as solriamfetol and psilocybin, there remains a significant lack of evidence-based pharmacological interventions for anorexia nervosa and a dearth of progress in pharmacotherapy for bulimia nervosa. Overall, the past 15 years have witnessed limited advancements in pharmacotherapy for EDs. There remains an urgent need for rigorous clinical trials in this area in addition to increased prioritization of ED research at the public health level to overcome longstanding barriers in the treatment of EDs."

Journal • Review • Anorexia • Binge Eating Disorder • Bulimia • CNS Disorders • Psychiatry

Drugs induced Raynaud's phenomenon and underlying mechanism: a disproportionality analysis from the WHO pharmacovigilance database. (PubMed, Arthritis Rheumatol) - "This study allowed us to identify robust safety signals (such as solriamfetol, tyrosine kinase inhibitors and CGRP inhibitors) for drugs associated with RP and potential implicated pathophysiological mechanisms."

Adverse events • Journal • Cardiovascular • CNS Disorders • Migraine • Oncology • Pain • Rheumatology

Comparative efficacy of new wake-promoting agents for narcolepsy-a network meta-analysis. (PubMed, BMC Neurol) - "All of the approved new wake-promoting drugs are effective in controlling narcolepsy symptoms with acceptable adverse effects. Trial Registration The study was prospectively registered in the INPLASY database (INPLASY2024120052)."

Journal • Retrospective data • Review • Cataplexy • CNS Disorders • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "AUVELITY net product sales were $136.1 million for the third quarter of 2025, representing 69% year-over-year growth, and 14% sequential growth compared to the second quarter of 2025. AUVELITY net product sales for the third quarter of 2024 were $80.4 million...SUNOSI net product revenue was $32.8 million for the third quarter of 2025, representing 35% year-over-year growth, and 9% sequential growth compared to the second quarter of 2025....SYMBRAVO net product sales were $2.1 million for the third quarter of 2025, the first full quarter of commercialization following its launch in June 2025."

Sales • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

PHARMACOLOGIC VS NONPHARMACOLOGIC INTERVENTION IN THE MANAGEMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNEA (CHEST 2025) - "Other pharmacologic treatments, including armodafinil, pitolisant, and solriamfetol, have demonstrated efficacy in improving wakefulness, particularly in patients with residual sleepiness. Excessive daytime sleepiness (EDS) is a major concern in obstructive sleep apnea (OSA), especially for those with persistent symptoms despite CPAP therapy. While CPAP remains the gold standard, other interventions offer potential benefits. Treatment options like carbocysteine and herbal remedies have shown promise in reducing EDS, though more research is needed."

Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Effect of sleep apnoea interventions on multiple health outcomes: an umbrella review of meta-analyses of randomised controlled trials. (PubMed, EClinicalMedicine) - "CPAP, wake stimulants, HNS, and myofunctional therapy significantly reduced daytime sleepiness (ESS score SMDs of -0.80 to -0.88; moderate-certainty evidence except for pitolisant and solriamfetol, which were supported by high-certainty evidence). Data need to be interpreted in the context of several limitations, including those relating to the meta-analysis inclusion criteria and the quality of data in the meta-analyses themselves. None."

HEOR • Journal • Cognitive Disorders • Obstructive Sleep Apnea • Pediatrics • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial. (PubMed, CNS Drugs) - P3 | "Solriamfetol demonstrated substantial efficacy and acceptable safety in Chinese patients with OSA with EDS, reinforcing its role as a viable treatment option."

Clinical • Journal • P3 data • Cardiovascular • Dyslipidemia • Excessive Daytime Sleepiness • Hypertension • Hypertriglyceridemia • Infectious Disease • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Drug Interactions With Excessive Daytime Sleepiness Treatments. (PubMed, J Pharm Technol) - "Objective: To evaluate the potential for drug interactions with pharmacotherapy for central hypersomnolence (modafinil, armodafinil, solriamfetol, pitolisant, sodium oxybate, methylphenidate, amphetamine, lithium, clarithromycin). Available literature indicates that pharmacotherapy for central hypersomnolence is associated with clinically significant drug interventions and subsequent possible adverse reactions. Clinicians in all practice settings should be mindful of the potential to minimize drug interactions and optimize pharmacotherapy for hypersomnolence."

Journal • Review • Excessive Daytime Sleepiness • Sleep Disorder

Potential treatments for attention-deficit/Hyperactivity disorder: a focus on phase III trials. (PubMed, Expert Opin Pharmacother) - "Stimulant medications, such as methylphenidate and amphetamine derivatives, and non-stimulant medications, such as atomoxetine, guanfacine, clonidine, and viloxazine, are considered the cornerstones of pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD)...We highlight four promising candidates: centanafadine, solriamfetol, CTx-1301, and NRCT-101SR...Additionally, multi-phase extended-release formulations may improve adherence and enhance symptom control throughout the day. As phase III data become available, these agents have the potential to redefine ADHD treatment paradigms."

Journal • P3 data • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Post-marketing safety of solriamfetol: A retrospective pharmacovigilance study based on the us food and drug administration adverse event reporting system. (PubMed, PLoS One) - "Solriamfetol-related adverse events were mainly psychiatric, neurological, cardiac, and general disorders, with headache, anxiety, and drug ineffectiveness being the most common. Nearly half of the events occurred within the first week of treatment. Given the limitations of the FAERS database, further prospective studies are needed to confirm these findings."

Adverse events • Journal • P4 data • Retrospective data • Excessive Daytime Sleepiness • Mood Disorders • Narcolepsy • Obstructive Sleep Apnea • Pain • Psychiatry • Respiratory Diseases • Sleep Disorder

Effect of sleep apnoea interventions on multiple health outcomes: umbrella review of meta-analyses of randomised controlled trials (ERS 2025) - "CPAP and wakefulness-promoting agents (solriamfetol, pitolisant, modafinil) effectively reduced daytime sleepiness. BP reduction was most significant with CPAP combined with diet/lifestyle changes. Knowledge gaps persist regarding non-CPAP therapies, adherence, and combination treatments, which likely represent the future of personalized OSA management."

Clinical • HEOR • Review • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment. (PubMed, J Psychopharmacol) - P4 | "Solriamfetol demonstrated good safety and efficacy in improving fatigue and executive functioning in patients with ME/CFS. As a dual norepinephrine-dopamine reuptake inhibitor and wakefulness-promoting factors, solriamfetol has the potential to improve fatigue symptoms of ME/CFS."

Journal • CNS Disorders • Fatigue • Infectious Disease • Narcolepsy • Obstructive Sleep Apnea • Pain • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics Highlights Data Across Its Leading Neuroscience Pipeline at Psych Congress 2025 (GlobeNewswire) - "Six poster presentations showcase clinical and real-world data in major depressive disorder, Alzheimer’s disease agitation, narcolepsy, and obstructive sleep apnea."

Clinical data • Alzheimer's Disease • Major Depressive Disorder • Narcolepsy • Obstructive Sleep Apnea

Comparative efficacy, safety and benefit/risk of alerting agents for excessive daytime sleepiness in patients with obstructive sleep apnoea: A network meta-analysis (WSS 2025) - "Pharmacological treatment options authorised in Europe and/or the United States are modafinil/armodafinil, solriamfetol, and pitolisant. Pitolisant, solriamfetol and modafinil had comparable efficacy for maintaining wakefulness in patients with OSA. Pitolisant had a better safety profile and benefit-risk ratio compared with solriamfetol and modafinil. The overall and cardiovascular safety risk ratios suggest that pitolisant might be the best candidate for OSA patients with multiple cardiovascular comorbidities."

Retrospective data • Cardiovascular • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Risk of Developing Tolerance During Treatment for Excessive Daytime Sleepiness in Patients with Narcolepsy (WSS 2025) - "No cases of cross-tolerance were observed among patients who switched medications, including those who switched to modafinil, solriamfetol, pitolisant, sodium oxybate, or methylphenidate. In this study, we found that modafinil was associated with the highest risk of tolerance development in patients treated for narcolepsy with cataplexy (EDS), whereas pitolisant was the most favorable in terms of the risk of tolerance. Additionally, two major patterns of modafinil tolerance development were observed: "early" tolerance, which occurred within the first two years of treatment, and "late" tolerance, which develops after five years of therapy. In contrast, solriamfetol and pitoliant mainly had cases of early tolerance."

Clinical • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Clinical Trial of Solriamfetol in Early Morning Shift Workers (WSS 2025) - P4 | "Solriamfetol significantly reduced the severity of illness and improved subjective functioning compared to placebo in participants with SWD who work early-morning shifts. www.clinicaltrials.gov (NCT04788953)."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline (GlobeNewswire) - "Dr. Chadwick will provide an overview of fibromyalgia and of the previously completed Phase 2 and Phase 3 clinical trials of AXS-14 in the indication...Dr. Cummings will provide an overview of Alzheimer's disease (AD) agitation and discuss the results of the ADVANCE and ACCORD Phase 3 trials of AXS-05 in the indication...Cutler will provide an overview of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), and excessive sleepiness associated with shift work disorder (SWD), and discuss the results of the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively...Dr. Tepper will provide an overview of migraine and will discuss results from the MOMENTUM and INTERCEPT Phase 3 trials of SYMBRAVO in the acute treatment of migraine with and without aura....Dr. Thorpy will provide an overview of narcolepsy and will discuss the results of the clinical trial program of AXS-12 in the indication."

Clinical data • Trial status • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Excessive Daytime Sleepiness • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy • Psychiatry • Sleep Disorder

Residual Excessive Daytime Sleepiness in Obstructive Sleep Apnoea and New Pharmacological Possibilities for Treatment. (PubMed, Arch Bronconeumol) - "Given the direct relationship between excessive daytime sleepiness (usually defined by an Epworth Sleepiness Scale [ESS] value of more than 10 points) and cardiovascular, neurocognitive and quality-of-life disorders, attempts have been made for years to alleviate it with drugs (modafinil, armodafinil, sodium oxybate or amphetamines), to little effect and with a large number of adverse effects. However, unlike their predecessors, two products that have recently appeared on the market - solriamfetol and pitolisant - have achieved clinically significant reductions without any major adverse effects, in most cases. In fact, a Task Force from the European Respiratory Society has even proposed an algorithm for residual excessive daytime sleepiness and its pharmacological treatment in the context of obstructive sleep apnoea. The present review aims to define the importance of excessive daytime sleepiness, especially residual excessive daytime sleepiness in patients with..."

Journal • Review • Cardiovascular • CNS Disorders • Excessive Daytime Sleepiness • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Commercial Highlights (GlobeNewswire) - "Payer coverage for AUVELITY in the commercial channel expanded by 28 million new covered lives as of July 1. Overall payer coverage for AUVELITY across all channels is now at approximately 83% of all lives covered, with the proportion of covered lives in the commercial and government (Medicare and Medicaid) channels at approximately 73% and 100%, respectively...Payer coverage for SUNOSI across all channels is at approximately 83% of all lives covered. The proportion of lives covered for SUNOSI in the commercial and government channels are approximately 95% and 60%, respectively...Effective July 1, Axsome has contracted with one of the three largest...(GPOs) for potential formulary coverage of SYMBRAVO....Payer coverage for SYMBRAVO across all channels is currently at approximately 38% of all lives covered. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are currently approximately 26% and 56%, respectively."

Commercial • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

Anticipated Milestones (GlobeNewswire) - "Regulatory and Commercial: AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025); AXS-12 for narcolepsy, NDA submission (4Q 2025)...Clinical Trial Initiations and Progress....Phase 3 trial of solriamfetol in ADHD in pediatric patients, initiation (4Q 2025); Phase 3 trial of solriamfetol in MDD with EDS, initiation (4Q 2025)."

FDA filing • New P2/3 trial • New P3 trial • Alzheimer's Disease • Excessive Daytime Sleepiness • Major Depressive Disorder • Narcolepsy

Axsome Therapeutics Reports Second Quarter 2025 Financial Results... (GlobeNewswire) - "AUVELITY net product sales were $119.6 million for the second quarter of 2025, representing 84% year-over-year growth, and 24% sequential growth compared to the first quarter of 2025. AUVELITY net product sales for the second quarter of 2024 were $65.0 million; SUNOSI net product revenue was $30.0 million for the second quarter of 2025, representing 35% year-over-year growth, and 19% sequential growth compared to the first quarter of 2025. SUNOSI net product revenue for the second quarter of 2025 consisted of $28.9 million in net product sales and $1.1 million in royalty revenue associated with SUNOSI sales in out-licensed territories....SYMBRAVO was launched on June 10, 2025, and had net product sales of $0.4 million for the second quarter of 2025. No SYMBRAVO sales were reported by Axsome for the comparable period in 2024 reflecting the timing of the product launch."

Sales • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

Solriamfetol for the treatment of excessive daytime sleepiness in participants with obstructive sleep apnea with different levels of adherence to primary OSA therapy: Subgroup analysis of a randomized clinical trial. (PubMed, Sleep Med) - "In the subgroup analysis of a randomized clinical trial in Chinese OSA participants with EDS, solriamfetol was effective and well tolerated regardless of adherence to primary OSA therapy. No clinically meaningful impact of solriamfetol on the use of primary OSA therapy was found."

Clinical • Journal • Cardiovascular • Excessive Daytime Sleepiness • Hypertension • Infectious Disease • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc...announced presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona."

Clinical data • Alzheimer's Disease • Depression • General Anxiety Disorder • Major Depressive Disorder • Narcolepsy